Job Description

Location Type: Remote

Position Overview

TetraScience is seeking a Compliance Manager to ensure the company's offerings adhere to industry-accepted standards such as GxP, ISO 9001, SOC 2 Type II, and relevant EU regulations. This role is pivotal in supporting customers' regulated and validated environments by working closely with Product, Engineering, and Quality teams. The Compliance Manager will also play a key role in developing, enhancing, and supporting TetraScience’s GxP Package, which aids customers in accelerating their validation processes.

Responsibilities

• Ensure TetraScience maintains compliance with current and future offerings for customers' regulated and validated environments.
• Collaborate with Product, Engineering, and Quality teams to ensure full compliance and adherence to current regulatory best practices.
• Participate in regular internal and external audits and maintain the Quality Management System to support current and future certifications.
• Help develop, enhance, and support TetraScience’s GxP Package to accelerate customer validation.
• Work with customers to ensure TetraScience's Products and Platform can be adapted to their compliance and quality team needs, including documentation and last-mile validation.
• Collaborate with Compliance, Product, Engineering, Training, and Quality Engineering teams to develop, support, and promote the GxP Package.
• Work with leadership to ensure organizational processes are consistent, automated, and enforced, acting as an independent check on cross-functional Quality efforts.
• Prepare TetraScience for customer audits/supplier assessments by conducting internal audits, planning for, and remediating process deviations.
• Address compliance questions from an EU regulatory perspective during Sales, Implementation, and Customer Engagements.
• Maintain and improve the Quality Management System, ensuring adherence to evolving EU compliance frameworks.
• Maintain all current compliance documentation per internal policy, including Engineering and Security Policies, SOPs, Employee training records, and validation documentation aligned with Pharma customer regulatory obligations.
• Maintain familiarity with all TetraScience products and components, with a specific focus on EU regulatory requirements.

Requirements

• 10+ years of experience with software lifecycle management, qualification, and validation testing regimens.

Company Information

Who We Are

TetraScience is the Scientific Data and AI Cloud company, catalyzing the Scientific AI revolution by designing and industrializing AI-native scientific data sets. We offer next-generation lab data management solutions, scientific use cases, and AI-enabled outcomes. TetraScience is the category leader in this market, with significant revenue and partnerships with dominant players in compute, cloud, data, and AI infrastructure.

The Tetra Way

Candidates will be asked to review the "Tetra Way" letter, authored by the co-founder and CEO, Patrick Grady. This document is crucial for understanding the company's values and ethos, and alignment with its unique approach to company and team building is expected.